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Featured Article

Contract Research Organizations,
The State of the Industry in North America
by Luc Péloquin, Ph.D.
Vice-President Life Sciences, Innovitech

Contract Research Organizations offer a wide array of services to their biotech or pharmaceutical clients. These services assist in the process of drug development and are therefore subject to regulation by organisms, such as the Food and Drug Administration (FDA).

CROs offer services in all areas of drug development including: discovery and preclinical testing, phase I testing on healthy volunteers, phase II on patient volunteers, phase III on patient volunteers on a larger scale, FDA review and approval, and phase IV post marketing testing.

Market Growth

The global market for contract research was at US$4 billion in the US, and US$2.6 billion in Europe in 2002 with an anticipated annual mean growth rate of 13% and 10%, respectively. The rest of the world accounts for less than US$1 billion.

The province of Quebec (and specifically the Greater Montreal area) is a recognized international hub for CROs. Its industry concentrates on phases I and II, has 4000 specialized jobs, and possesses 35% of the North American beds for phase I clinical trials. The phase I trials are mainly used for bioequivalence studies for generic drugs but some are done for first in human trials as well.

Market Trends

There are clear indicators that the CRO market will move to less developed countries in the near future. The main drivers for this move are the cost reduction and the chase for cohorts of untouched healthy and patient volunteers.

Increasing Safety of Clinical Trials

This trend is of an increasing concern to the global CRO industry. Its leaders are now looking at ways to retain their competitive edge in this market and one possible direction is to increase the safety of trials in North America & Europe. However, the main concern about the developing CROs in Eastern Europe and Asia is at the regulation level. There is no doubt they can reduce most afferent costs, however there is a learning curve in regulation, safety, and dealing with organizations such as the FDA. Increasing the level of safety, adding new testing and new electronic data handling systems will represent an additional barrier to entry for these emerging CROs.

Most major CROs already possess 21 CFR Part 11 compliant electronic data systems. As a result, this creates a new minimum level of compliance that the emerging CROs will have to reach in order to satisfy their clients' regulatory needs. Furthermore, these CROs are starting to support their sponsors throughout the exchange and collection of regulatory relevant documents.

"If we are unable to submit electronic records to the FDA according to FDA regulations, our ability to perform services for our customers which meet applicable regulatory requirements could be adversely affected."
SFBC Anapharm's annual report for 2003

Pharmacogenomics

The pharmaceutical industry is also moving toward the use of pharmacogenomics data, and the FDA recently published its guideline concerning the highly desired use of pharmacogenomics data in clinical trials. This trend is directed mainly toward the reduction of drug adverse effects that are making the news on a daily basis in the last few months. The leading North American and European CROs must offer pharmacogenomics testing in the near future to ensure they keep an edge on their market and to satisfy the compliance needs of their clients.



About Luc Péloquin
luc.peloquin@innovitech.com

Exceptionally involved in the field of Life Sciences and all of its levels; corporate development, commercialization, intellectual property and technological development, Luc Péloquin possesses an extensive work expertise in technological transfer and international commercialization of biotechnology.

Luc Péloquin has been working in the Life Sciences field for more than 30 years. He has worked initially as an academic researcher within university and hospital research groups as well as within provincial and federal government's research laboratories. Between 1995 and 2002, he occupied the position of Managing Director of Canadian operations and Corporate Vice-President R&D for QBiogene. Luc Péloquin sits on the board and executive committee of the CQIB, the firm incubator in biotechnology of the city of Laval. He is presently the Vice-President, Life Sciences at Innovitech.